Hydrocortisone by Twenty-First Century Healthcare Fund, L.L.C. / Westwood Laboratories Inc. / Hobe Laboratories Inc. HYDROCORTISONE shampoo

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Animal medication manufactured, distributed, or labeled by Twenty-First Century Healthcare Fund, L.L.C., Westwood Laboratories Inc., Hobe Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Hydrocortisone Acetate 0.50%

Purpose

Anti-itch

Uses:

to soothe: itching flea bites  dermatitis skin irritations eczema

Warnings

For external use only. Use for all adult dogs.

Keep Out of Reach of Children

and animals to avoid unintended consumption.

Do not use:

in eyes or nose where infection (pus) is present, since the drug may allow infection to be spread on pregnant animals. 

if product appears to be tampered with. Not for prolonged use.

Stop use and ask veterinarian

if redness, irritation, or swelling persists or increases.

Directions

rinse pet with warm water until coat is thoroughly wet

massage shampoo thoroughly into the coat

continue massaging and add water during the process to make sure the shampoo is thoroughly distributed through the coat

leave the pet in lather for 5-10 minutes keeping the pet warm and out of drafts

rinse thoroughly and dry

for best results use at least twice a week or as directed by a veterinarian

Individual result may vary

Other information

Store product in cool. dry place. Avoid temperatures above 86F.

Inactive Ingredients

Deionized Water, Sodium Lauryl Ether Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine. Cocamidopropylamine Oxide, PEG-3 Distearate,

Aloe Barbadensis Leal Juice, Lauryl Glucoside, Triethanolamine. Lactic Acid, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance.

Questions

(800) 530-2178

Label

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 60754-920
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
SODIUM LAURETH-2 SULFATE (UNII: ZZQ59TY3KG)
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
PEG-3 DISTEARATE (UNII: 8420ECX438)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
TROLAMINE (UNII: 9O3K93S3TK)
LACTIC ACID (UNII: 33X04XA5AT)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60754-920-08	237 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/06/2014

Labeler - Twenty-First Century Healthcare Fund, L.L.C. (081289135)

Registrant - Twenty-First Century Healthcare Fund, L.L.C. (081289135)

Establishment
Name	Address	ID/FEI	Business Operations
Westwood Laboratories Inc.		069926483	api manufacture, manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Hobe Laboratories Inc.		782069702	api manufacture, manufacture